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Drug-Device Combination Products: Notified Body Opinion Process
Drug-Device Combination Products: Notified Body Opinion Process

Course Description

This three-day course will give you a thorough understanding of the Notified Body application process as well as a comprehensive regulatory update. You will understand the responsibilities and expectations of Notified Bodies and get the necessary tools to achieve a good submission.
  • Notified Body (NB) application & review process
  • Regulatory requirements (EU MDR)
  • EN ISO13485:2016
  • General Safety and Performance Requirements (GSPR)
  • CE marking
  • Gain a comprehensive overview of the NB application process
  • Understand where the NB responsibility starts and ends
  • Design and development activities necessary for a successful NBO
  • Why EN ISO13485:2016 will help achieve a good submission
  • Understanding risks, requirements, and standards in the context of generating evidence of conformity
  • Using the GSPR checklist as a means to manage your design and development file

Drug-Device Combination Products: Notified Body Opinion Process

14 - 16 May 2024, Live Online Training
Regular price €1.850,00
Unit price
per 
James Pink

James Pink has over 20 years of experience in medical devices including 10 years as a lead auditor for European Notified Body. James is a contributor to several medical device standards committees including ISO13485, ISO 14971 and various product-related standards.

START TIMES

9:00 AM Vienna time

8:00 AM London time

3:00 AM New York time

12:00 AM Los Angeles time

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Course Description

This three-day course will give you a thorough understanding of the Notified Body application process as well as a comprehensive regulatory update. You will understand the responsibilities and expectations of Notified Bodies and get the necessary tools to achieve a good submission.
  • Notified Body (NB) application & review process
  • Regulatory requirements (EU MDR)
  • EN ISO13485:2016
  • General Safety and Performance Requirements (GSPR)
  • CE marking
  • Gain a comprehensive overview of the NB application process
  • Understand where the NB responsibility starts and ends
  • Design and development activities necessary for a successful NBO
  • Why EN ISO13485:2016 will help achieve a good submission
  • Understanding risks, requirements, and standards in the context of generating evidence of conformity
  • Using the GSPR checklist as a means to manage your design and development file

"Trainer is very competent and has the complete knowledge of the matter."

– Senior Process Expert, B. Braun

"It is not at all frequent to find this grade of preparation and reaction to specific cases such as the ones presented. I'm enthusiastic! Thanks really."

– Tech Transfer Lead, Novartis

"Thank you for sharing all the links and informative material. Very professional organization and execution."

– Manufacturing Manager, Thermo Fisher Scientific

"The trainer was very knowledgeable about the topics and was able to answer all questions."

– Drug Product Subject Matter Expert, Pfizer

"Excellent work of the lecturer, good materials, clear explanations."

– Clinical Pharmacologist, Boehringer Ingelheim

Drug-Device Combination Products: Notified Body Opinion Process

Download the full training agenda to reveal complete session details, training takeaways, case studies, daily schedule, special features and full trainer bio.

Medical-Devices-Certificate-Course

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